NCT05950269

Brief Summary

Older adults have higher rates of emergency department admissions when compared to their younger counterparts. Mobility is the ability to move around but also encompasses the environment and the ability to adapt to it. Walking aids can be used to improve mobility and prevent falls. According to international guidelines, they must be available in Geriatric Emergency Department. This study aims to evaluate the effectiveness of a program of training and provision of walking aids (WA), associated or not with telemonitoring, on mobility, quality of life, fear of falling, and risk of falls up to 3 months in older adults cared for in an emergency department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

July 10, 2023

Last Update Submit

April 22, 2025

Conditions

Keywords

GeriatricLife spaceWalking aidsEmergency roomClinical TrialMobility

Outcome Measures

Primary Outcomes (2)

  • Life-Space Assessment (LSA)

    LSA is a scale which allows the characterization of mobility in life-spaces specifically frequency, need for mobility aids and the help of third party in the last 4 weeks

    At baseline and after completion of the 3 and 6 months intervention to assess change

  • Falls Efficacy Scale International (FES-I)

    Assesses fear of falling

    At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change

Secondary Outcomes (9)

  • Timed Up and Go test (TUG)

    At baseline and immediately after the intervention

  • One-minute sit-to-stand test

    At baseline and after completion of the 3 and 6 months intervention to assess change

  • Katz index

    At baseline and after completion of the 3 and 6 months intervention to assess change

  • Barthel index

    At baseline and after completion of the 3 and 6 months intervention to assess change

  • Lawton-Brody scale

    At baseline and after completion of the 3 and 6 months intervention to assess change

  • +4 more secondary outcomes

Study Arms (3)

Walking aid (WA) group

EXPERIMENTAL

Participants will receive the walking aid and training in the use of the device.

Device: Walking aidOther: Guidance on safe walking and risk of falling

Walking aid with telemonitoring (WAT) group

EXPERIMENTAL

Participants will receive the walking aid and training in the use of the device associated with telemonitoring.

Device: Walking aidOther: TelemonitoringOther: Guidance on safe walking and risk of falling

Control group

OTHER

Participants will receive verbal guidance and printed material.

Other: Guidance on safe walking and risk of falling

Interventions

A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).

Walking aid (WA) groupWalking aid with telemonitoring (WAT) group

Telemonitoring will occur every two weeks for three months after the emergency department discharge, through video call (about 15 minutes). On these opportunities, the importance of using mobile devices and the guidance on safe gait will be reinforced.

Walking aid with telemonitoring (WAT) group

Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.

Control groupWalking aid (WA) groupWalking aid with telemonitoring (WAT) group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • Admitted to the Geriatric Emergency Department of Hospital Sírio-Libanês
  • Willing and able to give informed consent
  • Least one of the following for indication and training of mobility aids: reduction of postural instability; improvement of motor control; increase of somatosensory feedback; reduction of biomechanical overload; safe promotion of autonomy; fall history (in the last six months).

You may not qualify if:

  • Altered level of conscience
  • need for supplemental oxygen (≥3L/min)
  • respiratory distress
  • hemodynamic instability
  • postural instability with a tendency to fall backward
  • cognitive impairment that limits the use of walking aids
  • hospitalization after Emergency Department evaluation
  • Delirium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sírio Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Related Publications (7)

  • Kennedy RE, Williams CP, Sawyer P, Lo AX, Connelly K, Nassel A, Brown CJ. Life-Space Predicts Health Care Utilization in Community-Dwelling Older Adults. J Aging Health. 2019 Feb;31(2):280-292. doi: 10.1177/0898264317730487. Epub 2017 Sep 14.

    PMID: 29254407BACKGROUND
  • Shimada H, Sawyer P, Harada K, Kaneya S, Nihei K, Asakawa Y, Yoshii C, Hagiwara A, Furuna T, Ishizaki T. Predictive validity of the classification schema for functional mobility tests in instrumental activities of daily living decline among older adults. Arch Phys Med Rehabil. 2010 Feb;91(2):241-6. doi: 10.1016/j.apmr.2009.10.027.

    PMID: 20159128BACKGROUND
  • Brown CJ, Kennedy RE, Lo AX, Williams CP, Sawyer P. Impact of Emergency Department Visits and Hospitalization on Mobility Among Community-Dwelling Older Adults. Am J Med. 2016 Oct;129(10):1124.e9-1124.e15. doi: 10.1016/j.amjmed.2016.05.016. Epub 2016 Jun 8.

    PMID: 27288857BACKGROUND
  • van den Berg N, Schumann M, Kraft K, Hoffmann W. Telemedicine and telecare for older patients--a systematic review. Maturitas. 2012 Oct;73(2):94-114. doi: 10.1016/j.maturitas.2012.06.010. Epub 2012 Jul 17.

    PMID: 22809497BACKGROUND
  • Bateni H, Maki BE. Assistive devices for balance and mobility: benefits, demands, and adverse consequences. Arch Phys Med Rehabil. 2005 Jan;86(1):134-45. doi: 10.1016/j.apmr.2004.04.023.

    PMID: 15641004BACKGROUND
  • Polesel FS, Denadai S, Morinaga CV, Madalena IC, Aliberti MJR, Henrique EA, de Andrade-Junior MC, Nucci RAB, Yamaguti WP, Curiati PK, Righetti RF. Walking Aids and Locomotion Training in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2544535. doi: 10.1001/jamanetworkopen.2025.44535.

  • Polesel FS, Denadai S, Aliberti MJR, Morinaga CV, Andrade-Junior MC, Madalena IC, Yamaguti WP, Curiati PK, Righetti RF. Training and provision of mobility aids to promote autonomy and mobility of older patients in a geriatric emergency department: A protocol for a randomized controlled trial. PLoS One. 2024 Jul 31;19(7):e0304397. doi: 10.1371/journal.pone.0304397. eCollection 2024.

MeSH Terms

Conditions

Mobility LimitationEmergencies

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study will be blind for the researchers involved in the post-telemonitoring assessments. Also, the data will be analyzed by a researcher who is not involved in the interventions or the assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

July 31, 2023

Primary Completion

December 28, 2024

Study Completion

December 28, 2024

Last Updated

April 24, 2025

Record last verified: 2025-04

Locations